RecruitingPHASE1, PHASE2INTERVENTIONAL

Trial of THEO-260 in Ovarian Cancer Patients

This research study is investigating a new treatment called THEO-260 for women with advanced ovarian cancer. THEO-260 is an oncolytic virus, which means it's a type of virus designed to infect and kill cancer cells. The main goal of this early-stage trial is to find a safe and well-tolerated dose of THEO-260. Researchers will also look for any early signs that the treatment is working against the cancer. Participants will receive THEO-260 directly into their bloodstream. This study is specifically for women aged 18 and over, whose ovarian cancer has returned or progressed despite standard chemotherapy treatment, or for whom standard treatments are not suitable.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Theolytics Limited

Enrolment target

Start

24 Sep 2024

Estimated completion

01 Jun 2028

Ovarian Cancer

What is this study about?

This study is about a new treatment for advanced ovarian cancer called THEO-260. Ovarian cancer is a type of cancer that starts in the ovaries, which are part of a woman's reproductive system. When cancer is 'advanced', it means it has grown or spread. Sometimes, standard treatments like chemotherapy might stop working, or cancer might come back. That's why researchers are always trying to find new and better ways to fight it.

THEO-260 is a special kind of virus, sometimes called an 'oncolytic virus'. This virus is designed to specifically target and destroy cancer cells, while hopefully leaving healthy cells alone. In this study, the virus will be given directly into the bloodstream through a drip. Because this is a very new treatment, the first important step is to find out if it's safe and if people can tolerate it well. Researchers will give different doses to different groups of patients to find the best dose.

Once they find a safe dose, they will also be looking for early signs that THEO-260 is having an effect on the cancer. This doesn't mean it's a cure, but even small signs that the treatment is shrinking tumours or stopping them from growing further can be very encouraging for future studies. This research is important because it could lead to new treatment options for women with ovarian cancer when other treatments are no longer effective.

Key takeaways

This study is testing a new virus-based treatment (THEO-260) for advanced ovarian cancer.
It's an early-stage trial focusing on finding a safe dose and seeing if it shows early signs of working.
It's for women aged 18+ whose ovarian cancer hasn't responded well to standard treatments.
Participants will receive the treatment through a drip and have regular health checks and scans.
There are potential benefits and risks, which will be fully explained before you decide to join.

Who may be eligible?

This study is particularly looking for women aged 18 or older who have advanced ovarian cancer. This includes specific types, such as high-grade serous or endometrioid cancer, which have been confirmed by a biopsy. It's important that your cancer has come back or worsened within six months after platinum-based chemotherapy, or if it didn't respond to platinum treatment in the first place. You also need to be well enough to take part, meaning you can look after yourself for the most part.

There are also some reasons why someone might not be able to join. For example, if you've had other anti-cancer treatments very recently (within the last 28 days or five 'half-lives' – a way of measuring how long a drug stays in your body), or if you're already in another drug trial. You also can't have had certain types of virus treatments before or significant heart or lung problems. The doctors will check your full medical history to make sure the trial is safe for you.

Finally, if you have certain active infections like hepatitis, tuberculosis, or COVID-19, or if you have cancer that has spread to your brain (unless it's been successfully treated and stable), you wouldn't be able to join this study. It's all about ensuring the safety of the participants and making sure the results of the study are clear.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman aged 18 or older?
Do you have advanced ovarian cancer (high-grade serous or endometrioid type) confirmed by biopsy?
Has your cancer come back or worsened after platinum-based chemotherapy, or didn't respond to it?
Are you generally well enough to manage your daily activities?
Have you discussed any recent cancer treatments or ongoing infections with your doctor?
Do you have any serious heart, lung, or brain conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the study drug, THEO-260, through an intravenous drip, which means it goes directly into your bloodstream. The doctors and nurses will monitor you very closely, especially in the beginning, to see how your body reacts to the new treatment. This will involve regular hospital visits, blood tests, and scans (like CT scans) to check the size of your tumours and your overall health.

These visits will happen often at first, and then less frequently as the study progresses. The total length of your participation will depend on how you respond to the treatment and what the study doctors decide is best for you. There will also be follow-up appointments even after you stop receiving the study drug to continue monitoring your health and the progress of your cancer. The exact schedule will be explained in detail by the study team.

Potential risks and benefits

As this is an early-stage study, the main potential benefit is that THEO-260 might help to control your ovarian cancer, especially if other treatments haven't worked for you. However, it's important to remember that this is a new drug, and we don't fully know how effective it will be. There are potential risks, as with any new treatment, which could include side effects from the virus or the treatment itself. These could range from mild, like feeling tired or sick, to more serious effects. The study team will explain all known and potential side effects in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Centro Integral Oncológico Clara Campal (CIOCC) Hospital
Verified postcode
Madrid, Spain· Recruiting
The Beatson West of Scotland Cancer Centre
Verified postcode
Glasgow, United Kingdom· Recruiting
Imperial College Healthcare NHS Trust, Hammersmith Hospital
Verified postcode
London, United Kingdom· Recruiting
Oxford University Hospitals NHS Foundation Trust, Churchill Hospital
Verified postcode
Oxford, United Kingdom· Recruiting

Common questions

What is an 'oncolytic virus'?

It's a special type of virus that has been designed to attack and destroy cancer cells specifically, while trying to leave healthy cells unharmed.

Will I still receive my usual cancer care?

Taking part in a clinical trial means you're receiving an experimental treatment, but your overall care will still be managed by your medical team. They will ensure you receive appropriate supportive care.

How long will the treatment infusions take?

The time for each infusion will vary and will be explained by the study team, along with the schedule of how often you'll receive the treatment.

What kind of monitoring will I have?

You'll have regular blood tests, physical examinations, and scans (like CT scans) to check your health and how the treatment is affecting your cancer.

Can I stop participating in the study if I want to?

Yes, you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

How to find out more

Clinical Trials

clinicaltrials@theolytics.com +441865607020 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.